What side effects are associated with this type of intervention?

Common treatments for Semantic Dementia, such as cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine), often have side effects including gastrointestinal issues (nausea, diarrhea), headaches, dizziness, and potential cardiovascular effects. For myeloperoxidase inhibitors like Verdiperstat, while specific side effects are not well-documented, similar agents may cause gastrointestinal discomfort, liver enzyme abnormalities, and potential hematologic effects. It is important to monitor patients closely for any adverse reactions during treatment.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Semantic Dementia mentioned in the provided context. Verdiperstat, a myeloperoxidase inhibitor, is currently being studied for its potential benefits in treating semantic variant primary progressive aphasia (svPPA) due to TDP-43 pathology. Broader treatments for related neurodegenerative conditions, such as Alzheimer's disease, include drugs like aducanumab, which targets amyloid plaques, and antioxidants like vitamin E. However, these treatments are not specifically approved for Semantic Dementia.

What other types of research exist?

Promising novel alternatives to Verdiperstat for Semantic Dementia (svPPA) patients include gosuranemab, an anti-tau monoclonal antibody, and SM07883, a potent, selective oral DYRK1A inhibitor. Both target mechanisms relevant to neurodegenerative diseases and have shown potential in clinical trials.

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Verdiperstat for Frontotemporal Dementia (Veri-T-001 Trial)

Phase 1

Recruiting

Research Sponsored by Peter Ljubenkov, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to swallow pills whole without crushing or chewing

MRI at screening is consistent with the underlying svPPA with no large strokes or severe white matter disease (Fazekas Grade ≤2; Fazekas et al. 1987)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Veri-T-001 Trial Summary

This trial is testing a new drug to see if it is safe and works well in patients with a certain type of dementia.

Who is the study for?

This trial is for adults aged 18-85 with semantic variant primary progressive aphasia due to TDP-43 pathology. Participants must be able to swallow pills, have a study partner, and agree to contraception if of childbearing potential. Exclusions include significant cardiovascular, renal or hepatic disease; recent immunosuppressants use; certain blood disorders; uncontrolled thyroid disease; major psychiatric illness; and known sensitivity to Verdiperstat's ingredients.Check my eligibility

What is being tested?

The Veri-T trial is testing the safety and effectiveness of Verdiperstat taken twice daily by patients with svPPA due to FTLD-TDP. The study will last for 24 weeks where three-fourths of participants receive Verdiperstat and one-fourth receive a placebo.See study design

What are the potential side effects?

While specific side effects are not listed here, common concerns in trials like this may include digestive issues, potential allergic reactions, changes in mood or behavior, fatigue, headaches or other neurological symptoms.

Veri-T-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills whole without needing to crush or chew them.

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My MRI shows svPPA without major strokes or severe brain damage.

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I am between 18 and 85 years old.

Veri-T-001 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Changes in Pharmacokinetic properties of Verdiperstat in Cerebrospinal Fluid (CSF)

Changes in Pharmacokinetic properties of Verdiperstat in Plasma

Other outcome measures

Change in Clinical Dementia Rating Scale (CDR-SB)

Change in Executive brain function

Change in brain volume on brain MRI

+7 more

Side effects data

From 2022 Phase 2 & 3 trial • 167 Patients • NCT04436510

28%

Nausea

21%

Headache

20%

Insomnia

19%

Fall

19%

Constipation

17%

Muscular weakness

16%

Fatigue

13%

Neuromyopathy

10%

Dizziness

10%

Dysphagia

10%

Tension headache

10%

Decreased appetite

Blood thyroid stimulating hormone increased

Diarrhoea

Salivary hypersecretion

Dyspnoea

Urinary tract infection

Anxiety

Oedema peripheral

Arthralgia

Back pain

Urine odour abnormal

Cough

Dysarthria

Pain in extremity

Febrile neutropenia

Respiratory failure

Pulmonary embolism

Amyotrophic lateral sclerosis

Ileus

Failure to thrive

Deep vein thrombosis

Dehydration

B-cell lymphoma

Acute respiratory failure

Abdominal pain

Hepatic enzyme abnormal

Aphasia

Cerebral infarction

Bacteraemia

Bacterial sepsis

COVID-19

COVID-19 pneumonia

Sudden death

Hip fracture

100%

80%

60%

40%

20%

Study treatment Arm

Matching Placebo

Verdiperstat

Veri-T-001 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VerdiperstatExperimental Treatment1 Intervention

Verdiperstat 2 tablets twice daily (600mg total daily) by mouth for 24 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Placebo 2 tablets twice daily by mouth for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Verdiperstat

2019

Completed Phase 3

~610

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Verdiperstat, a Myeloperoxidase Inhibitor, is being studied for its potential to treat Semantic Dementia by targeting neuroinflammation. Myeloperoxidase is an enzyme involved in the production of reactive oxygen species, which can contribute to oxidative stress and inflammation in the brain. By inhibiting this enzyme, Verdiperstat aims to reduce neuroinflammation and oxidative damage, which are believed to play a role in the progression of neurodegenerative diseases like Semantic Dementia. This mechanism is crucial for patients as it addresses underlying pathological processes, potentially slowing disease progression and improving cognitive function.

Memantine for dementia.Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial.Utilizing combination therapy in the treatment of Alzheimer's disease.